Kornimate/medical-research-clean huggingface dataset:
a phase 1/2 study of hki-272 (neratinib) in combination with paclitaxel (taxol) in subjects with solid tumors and breast cancer

Conditions: Advanced Breast Cancer; Advanced Malignant Solid Tumors; Breast Neoplasms

Summary: the purpose of this study is to learn whether it is safe and effective to administer hki-272 (neratinib) in combination with paclitaxel in patients with breast cancer.


Eligibility criteria:
inclusion criteria: inclusion criteria for both parts of clinical trial: * good performance status * normal ejection fraction * adequate cardiac, kidney, and liver function * adequate blood counts * at least one measurable target lesion * negative pregnancy test for female subjects inclusion criteria for part 1 only: - pathologically confirmed solid tumor not curable with available standard therapy inclusion criteria for part 2 only: * pathologically confirmed breast cancer * her2 positive tumor * prior treatment with herceptin exclusion criteria: exclusion criteria for both parts of clinical trial: * major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1 * subjects with bone or skin as the only site of disease * active central nervous system metastases * significant cardiac disease or dysfunction * significant gastrointestinal disorder * inability or unwillingness to swallow hki-272 capsules * prior exposure to hki-272 or other her2 targeted agents, except trastuzumab (part 2 only). prior lapatinib is permitted in arm b of part 2. * treatment with a taxane within 3 months of treatment day 1 * grade 2 or greater motor or sensory neuropathy * pregnant or breast feeding women * known hypersensitivity to paclitaxel or cremophor el * prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2 * any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin exclusion criteria for part 2 only: - more than 1 (arm a) or 3 (arm b) prior cytotoxic chemotherapy regimen for metastatic disease

Keywords: cancer hki-272 neratinib paclitaxel taxol breast cancer nerlynx
a one-year safety study of flibanserin to treat pre-menopausal women with hypoactive sexual desire disorder (hsdd).

Conditions: Sexual Dysfunctions, Psychological

Summary: to determine if long-term treatment with flibanserin is safe and to monitor the effectiveness of flibanserin in women with hsdd that have already completed a previous study (511.70/71/.74/.75/.105) with flibanserin.


Eligibility criteria:
inclusion criteria: 1. women with a primary diagnosis of hsdd who have completed a previous study of flibanserin. 2. patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study. 3. patients must be reliable, compliant, and agree to cooperate with all study evaluations. 4. patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff. exclusion criteria: 1. a history of major depressive disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt. 2. participation in another clinical trial within 1 month prior to the start of the study, except for flibanserin. 3. patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. 4. patients who are pregnant or have been pregnant within 1 month prior to study start. 5. patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about hsdd. 6. clinically significant ecg or lab abnormalities at study start. 7. patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
the role of cytomegalovirus and inflammation on patient symptoms and outcomes in ovarian cancer

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: cytomegalovirus (cmv), a widely prevalent virus in the general us population, has been shown to be associated with increased inflammation and mortality. previous small pilot studies have demonstrated that latent cmv may be reactivated during chemotherapy in cancer patients, and may be associated with unfavorable cancer outcomes such as fatigue and increased mortality. the central research idea for this study, supported by previous preliminary data, is that cmv reactivation is an unrecognized complicating factor in the treatment of ovarian cancer that impacts patient outcomes. the overarching goals of this observational study are: * to assess how cmv infection is associated with ovarian cancer symptoms over the course of the disease and its treatment. * to describe the relationship between cmv reactivation in ovarian cancer patients, survival, fatigue, and other qol outcomes, both cross-sectionally and longitudinally.


Eligibility criteria:
inclusion criteria: * age ≥18 * ability to read and write in english * women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer * treatment plan includes chemotherapy * able to provide written voluntary consent before performance of any study related procedure. * cohort 1 only: within 2 years of completing initial chemotherapy treatment * cohort 2 only: prior to starting chemotherapy exclusion criteria: * inability to provide informed written consent * previous exposure to chemotherapy * life expectancy \< 3 months or in hospice care or nursing home
metabolic effects of early time-restricted carbohydrate consumption

Conditions: Diabetes Mellitus, Type 2; Obesity; Nutrition, Healthy; Weight Loss

Summary: in this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes


Eligibility criteria:
inclusion criteria: * age 18-75 years * both males and females * type 2 diabetes exclusion criteria: * type 1 diabetes * insulin treatment * pharmacological treatment for weight loss * pregnancy * other acute or chronic conditions influencing body weight and glucose metabolism
eflornithine + nifurtimox late-stage human african trypanosomiasis (hat)in west nile, uganda

Conditions: Trypanosomiasis, African

Summary: this case series study follows on a terminated randomised clinical trial in a nearby location of uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. the study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage human african trypanosomiasis (sleeping sickness) patients.


Eligibility criteria:
inclusion criteria: * stage 2 infection with trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) presence of trypanosomes in blood or lymph node fluid and wbc count in csf \> 5 / mm3, or (ii) presence of trypanosomes in the csf with any csf wbc count * residence in the study area * written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition) exclusion criteria: * pregnancy or clinical history suggestive thereof * weight \< 10 kg * history of any hat treatment within the previous 24 months * inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge * severe anemia (hb\< 5g/dl) * active tuberculosis (sputum positive) * hiv positive (if patient has been tested and results are known) * severe renal or hepatic failure * bacterial or cryptococcal meningitis * other severe underlying diseases upon admission * refugee status

Keywords: human african trypanosomiasis sleeping sickness trypanosoma brucei gambiense combination eflornithine nifurtimox human african trypanosomiasis (sleeping sickness) due to trypanosoma brucei gambiense in the late stage (stage 2 or meningo-encephalitic)
effectiveness of rtms with double-cone-coil in patients with major depression

Conditions: Depression

Summary: repetitive transcranial magnetic stimulation (rtms) is used to modulate the neuronal excitability in patients with depression. in the present study the investigators will examine whether medial frontal rtms using a double-cone-coil proves to be superior to conventional high-frequency-rtms applied to the left-sided prefrontal cortex with a butterfly-coil.

depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy levels and poor concentration. these problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday's responsibilities, at its worst, depression can lead to suicide. depression can be reliably diagnosed in primary care. antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80% of those affected and can be delivered in primary care. in patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. high-frequency rtms of the dorsolateral prefrontal cortex (dlpfc) has been investigated for the treatment of hypoexcitability disorders. mild antidepressant effects of rtms applied to the left sided dorsolateral prefrontal cortex (dlpfc) using a standard butterfly coil can possibly be increased by a different stimulation protocol over the medial frontal cortex using a double-cone-coil. first hints to effectiveness of this treatment arise from case reports and therefore need replication and comparability to conventional stimulation protocols. in the present study the investigators will examine whether medial frontal rtms using a double-cone-coil proves to be more effective to conventional high-frequency-rtms applied to the left-sided prefrontal cortex with a butterfly-coil.

Eligibility criteria:
inclusion criteria: * episode of depression (unipolar or bipolar)( icd-10) * female or male between 18 and 70 years old * skills to participate in all study procedures * 18 or more points in the hamilton rating scale or depression * stable antidepressant drugs * written informed consent exclusion criteria: * clinically relevant unstable internal or neurological comorbidity * evidence of significant brain malformations or neoplasm, head injury * cerebral vascular events * neurodegenerative disorders affecting the brain or prior brain surgery * metal objects in and around body that can not be removed * pregnancy * alcohol or drug abuse * epilepsy or a pathological eeg * heart pacemaker * high dose tranquillizers

Keywords: depression transcranial magnetic stimulation rtms dlpfc medial frontal cortex anterior cingulate complex
cross-sectional study: prevalence of restless legs syndrome in patients with unpleasant sensations of the legs

Conditions: Restless Legs Syndrome

Summary: the proposed study is a cross-sectional epidemiological study, performed in 330 primary care practices in germany. the study will be conducted on a fixed day in november 2007. primary care surgeries throughout germany will be asked to take part. the study material will be delivered to the surgery by a member of sales-force who will also explain the study conduct to the physician/staff. physicians who want to take part in the study will send a signed contract to bi. physicians will be trained to diagnose rls. all patients attending the participating surgeries on a fixed day will be invited to participate in the study. the patients will be handed a questionnaire to fill out while waiting for their appointment. no patient-related data apart from gender and year of birth will be recorded on the questionnaire and it will be ensured that no re-identification of patients is possible. therefore, no written informed consent will be obtained from the participants. the patient questionnaire will consist of the following items: a screening questionnaire for rls (according to stiasny-kolster et. al., data on file) additional questions concerning the impact of the patients leg problems on daily life. the practice staff will then collect the questionnaire. all patients who have answered question 1 (asking for unpleasant sensations of the legs) with ¿yes¿ will subsequently be assessed for the diagnosis by the physician. the physician fills out a second questionnaire, covering the following items: diagnosis (cause of leg problems) concomitant diagnoses and therapies if the diagnosis of rls was made: consequences (therapy)? was the diagnosis of rls pre-known? all completed questionnaires will be sent to data management by the surgery within 2 working days.


Eligibility criteria:
inclusion criteria: * patients attending one of the participating primary care surgeries on a fixed day * male or female patients of any age exclusion criteria: * patients who only attend the practice to get a prescription and are not seen by the doctor on that day. * patients who are not able to understand the questionnaire due to mental impairment or language problems. * children and adolescents under the age of 18 years
study of alvimopan for the management of opioid-induced postoperative bowel dysfunction/postoperative ileus

Conditions: Ileus

Summary: patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (poi), occurring in nearly all cases. signs and symptoms of poi may include abdominal distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. this study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of gi function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

postoperative ileus (poi) is temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. this functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. when poi persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged poi, and increases the risk for related morbidity. no drug therapy has been shown to consistently shorten the duration of poi. this study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of gi function in patients undergoing bowel resection of hysterectomy.

Eligibility criteria:
inclusion criteria: * subject is scheduled for a partial small/large bowel resection of primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy * subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (pca) opioids exclusion criteria: * subject is scheduled for a total colectomy, colostomy, ileostomy * subject has complete bowel obstruction * subject is currently taking opioid analgesics or has taken opioid analgesics within 4 weeks prior to surgery

Keywords: postoperative ileus
internet-administrated treatment of anxiety symptoms for young adults

Conditions: Anxiety Disorders; Depression

Summary: the purpose of this study is to determine whether tailored internet-administrated cbt is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting.


Eligibility criteria:
inclusion criteria: * be between the ages of 16-25 years old * have anxiety symptoms and/or anxiety syndrome exclusion criteria: * suicide prone * alcohol addiction * ongoing psychological treatment
wallis stabilization system for low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to demonstrate that the wallis system (interspinous process implant) is equivalent to total disc replacement (tdr) for the treatment of mild to moderate degenerative disc disease (ddd) of the lumbar spine at the l4-l5 level. this study will assess the safety and efficacy of the wallis® system compared to commercially available lumbar tdr with respect to individual subject success rates at 24 months postoperative follow-up. study participants will receive all study related test articles and surgical procedures at no charge. please scroll down to the "locations" section to find a doctor in your area that is participating in this study. if you are interested in participating in this study and do not see a doctor in your area, please contact jose naveira at jose.naveira@abbottspine.com


Eligibility criteria:
inclusion criteria: * age 18-60 (inclusive) and skeletally mature. * diagnosis of mild to moderate ddd at l4-l5 as confirmed by radiography. * minimum of six months of failed conservative treatment. * pre-operative visual analog (vas) low back pain score ≥ 40, on a scale of 100mm, with low back pain greater than left or right leg pain. * preoperative baseline oswestry disability index (odi) score of ≥ 40 on a 100 point scale. * physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol. * voluntarily signs the patient informed consent form. * patient is a surgical candidate for an anterior approach to the lumbar spine (\< 3 abdominal surgeries). exclusion criteria: * the investigator believes that the l1-l2, l2-l3, l3-l4, or l5-s1 level is symptomatic based upon objective evidence, e.g., radiograph, mri, or discography. * evidence of a prior fracture or trauma to the vertebral bodies at the affected level and/or the spinous processes at the l4-l5 or adjacent levels. * osteoporosis or osteopenia or metabolic bone disease as confirmed by dexa scan (t score \< -1.0). female subjects older than 45 years of age (or post-menopausal women, history of oophorectomy, or family history of osteoporosis) and male subjects older than 55 years will undergo a pre-operative, dual energy x-ray absorptiometry (dexa) of the lumbar spine. the dexa will be used to identify subjects with an indication of osteoporosis, osteopenia or metabolic bone disease. subjects with a t-score of less than -1.0 will be excluded from the study. * congenital lumbar spinal stenosis. * bony lumbar stenosis. * extreme obesity, as defined by national institutes of health (nih) clinical guidelines body mass index (bmi \> 40kg/m2). * a history of any surgical procedure intended to remove or alter the disc (e.g. discectomy, intradiscal electrothermal therapy (idet) or enzymes), decompress (laminectomy) or fuse, either the index or adjacent levels. * prior participation in study of any investigational spinal implant or investigational spinal treatment.

Keywords: degenerative disc disease total disc replacement
opioid counseling in pain management

Conditions: Pain, Postoperative

Summary: the purpose of this study is to evaluate the effect of perioperative opioid counseling within a specific group of patient population who are undergoing bilateral reduction mammoplasty.

prescription opioid abuse has been increasing dramatically in recent years. there is growing concern regarding the unprecedented increase in morbidity and mortality related to the use of opioids.1-2 in 2010 the rates of opioid sales, deaths, as well as associated treatment admissions have increased to more than triple the rates in 1999.1-2 although policy makers and the media often associate the opioid crisis as a problem of nonmedical opioid abuse, evidence has suggested that opioid addiction occurs in both medical and nonmedical users.2 the centers for disease control and prevention reported and warned that long-term opioid use often starts with treatment of some type of acute pain.3 prescription opioids have been shown to be favorable in perioperative pain management, however, their effectiveness in chronic pain management is not as clear. surgeons are among the highest opioid prescribers. many common elective as well as trauma-related procedures have been reported as possible causes of increased prolonged opioid usage. recent evidence also suggested that a considerable number of patients who were prescribed opioids struggle to with transitioning to non-opioid pain medications.1-6 numerous methods have been considered and explored in effort of decreasing the misuse and abuse of prescription opioids. one of the methods being opioid counseling, in which patients are educated on the effects and risks of short-term and long-term opioid usage and physicians recommend and discuss the appropriate opioid usage as well as alternative nonopioid options. it has also been indicated that counseling is more effective if given earlier on in the patient's surgical care rather than through rushed education overview at discharge.1,4-6 therefore, the purpose of this study is to evaluate the effect of perioperative opioid counseling within a specific group of patient population who are undergoing bilateral reduction mammoplasty.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * elective bilateral reduction mammoplasty to be performed as outpatient * able and willing to provide informed consent * able and willing to comply with study procedures exclusion criteria: * age \< 18 years * bilateral reduction mammoplasty planned/performed with any concomitant procedures * history of preoperative opioid consumption or rehabilitation * opioid allergy * local anesthetic given during or after procedure * unable and/or unwilling to provide informed consent * unable and/or unwilling to comply with study procedures

Keywords: opioid counseling bilateral reduction mammoplasty
otolith function in patients with primary ciliary dyskinesia

Conditions: Primary Ciliary Dyskinesia

Summary: the purpose of this study is to determine whether patients with primary ciliary dyskinesia (pcd) have reduced or absent otolith function.the otolith system is a specific part of the inner ear vestibular (balance) system that detects linear movement.

primary ciliary dyskinesia (pcd) is a genetically inherited condition. it is due to structural abnormalities of cilia, which are microscopic hairs found in organs and cells throughout the body. patients with this condition typically develop upper respiratory tract symptoms such as sinusitis and glue ear, lower respiratory tract problems such as recurrent chest infections, and fertility problems. there is currently no evidence that patients with pcd have a higher incidence of balance problems. however, recent animal studies have shown that cilia may also be important in the development of part of the inner ear balance (vestibular) system, specifically the part that detects linear movement known as the otolith system. the investigators hope to determine whether patients with pcd have absent or reduced otolith function compared to the normal population. balance problems are not currently screened for in pcd patients, and could be unrecognized and therefore untreated. it is also possible that pcd patients have compensated for absent otolith function and so are unaffected under normal circumstances; any additional insult to their balance system would cause more pronounced difficulties than expected and treatment might need to reflect this.

Eligibility criteria:
inclusion criteria: * aged 16-30 years * confirmed diagnosis of pcd under the care of the pcd team at the royal brompton hospital exclusion criteria: * aged under 16 years * unconfirmed or "suspected" pcd * previous history of balance disorders or diagnoses * previous history of sensorineural hearing loss * previous middle or inner ear surgery (other than grommet insertion)

Keywords: primary ciliary dyskinesia otolith vestibular tests